DEVICE: Park 1 (04049584000217)

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Device Identifier (DI) Information

Park 1
65000

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
04049584000217
GS1
1
The PARK 1 combines three measuring functions in one unit. Auto-Refractometer An infrared light source projects measuring light onto the retina of the eye from where it is reflected back to the shutter location. Sensitive sensor chips, or CCD cameras now register the deviation of the reflected light from the shutter location. The deviation depends on the ametropia. From that, an integrated microcomputer calculates the ametropia in D, based on the sphere, cylinder and cylinder axis position. 1 Measuring ocular / Patient eyepiece 4 Chin rest 2 Keratometer ring 5 Marking for the eye height 3 Pachycam camera glass cover Keratometer To determine the curvature of the cornea, a reflected image of the cornea is captured by a camera sensor and is measured. The reflection of test marks and of a ring is used as the reflected image. This allows the central radii of the cornea to be determined. Pachymeter The pachymetry principle uses Scheimpflug images of the cornea, which are analysed by a built-in computer. 600 Absolute data points are evaluated with the Scheimpflug image. The measuring range lies on a 4 mm slit through the apex. The slit light illuminates a sectional plane from the front surface of the cornea to the back surface. The transparent cells of the cornea scatter the slit light such that the sectional plane appears as if it were self-luminous. This is captured at an angle of 45° through the pupil by a camera, whereby the image plane of the camera is also tilted 45° to the optical axis of the camera lens, in order to sharply focus the light-scattering cornea plane onto the image plane of the camera (Scheimpflug image). Thanks to this arrangement, sharp sectional images of the cornea can be attained.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ophthalmic refractometer, manual A manually-operated ophthalmic device used to measure the refractive error of the eye (the inaccuracies of focusing of light upon the retina); typically the measurements are made in dioptres (the reciprocal of the focal length of the lens expressed in metres). Using this information the optometrist can calculate the lens prescription needed to correct the patient's refractive error. With advanced instruments the measurements are made automatically with printed verification.
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FDA Product Code

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Product Code Product Code Name
HLQ Keratoscope, Ac-Powered
HKO Refractometer, Ophthalmic
MXK Device,Analysis,Anterior Segment
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -10 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
Weight: 12 Kilogram
Depth: 530 Millimeter
Width: 538 Millimeter
Height: 265 Millimeter
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Device Status

In Commercial Distribution
September 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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